Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

NCT04534075 | Completed Phase 3 DMC

• 3 other identifiers: ALFGBG-926 4212018-029662020-01-07-02
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.

Conditions

Malignant Neoplasm; Malignant Neoplasm of Rectum; Malignant Neoplasm of Anus; Malignant Neoplasm of Urinary Bladder; Malignant Neoplasm of Cervix; Malignant Neoplasm of Ovary; Malignant Neoplasm of Prostate; Malignant Neoplasm of Large Intestine; Malignant Neoplasm of Colon; Gynecologic Cancer

Keywords

Radiotherapy; Irradiation; Radiation therapy; Dietary fiber; Psyllium husk; Placebo-controlled; Double-blind; Randomized; Patient-reported outcomes; ePROMS; Gut-wall inflammation; Late adverse effects; Late effects; Treatment-induced cancer survivorship diseases; Treatment-induced cancer survivorship syndromes; Intestinal health; Bowel health; Urgency; Leakage; Mucus; Flatulence; Blood discharge

Outcome Measures

Primary Outcomes (2)

• Sign of inflammation i blood

  Concentration of c-reactive protein in plasma or serum

  One month after the end of radiotherapy

• Intensity of the urgency syndrome

  Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the urgency syndrome weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.

  One year after the end of radiotherapy

Secondary Outcomes (4)

• Tolerance to additional dietary fiber

  During radiotherapy

• Signs of inflammation i blood

  One month after the end of radiotherapy

• Intensity of the fecal-leakage syndrome, uncontrolled flatulence, excess mucus discharge and blood

  One year after the end of radiotherapy

• Acute side-effects

  During radiotherapy, primarily during week 3

Other Outcomes (1)

• Composition of microbiota

  During, one month and one year after radiotherapy

Study Arms (2)

Additional dietary fiber through Psyllium husk

EXPERIMENTAL

The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. Altogether the fifteen capsules contains 5.5 g dietary fiber in psyllium husk.

Biological: Capsules containing either dietary fiber or placebo

Placebo (no additional dietary fiber)

PLACEBO COMPARATOR

The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. The capsules contain placebo (maltodextrin) and have a similar look as in the experimental arm.

Biological: Capsules containing either dietary fiber or placebo

Interventions

Capsules containing either dietary fiber or placebo BIOLOGICAL

The participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo.

Additional dietary fiber through Psyllium husk; Placebo (no additional dietary fiber)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned preoperative (neoadjuvant) or curative radiation therapy for a tumor in the pelvic cavity (including all forms of gynecological cancer, colorectal cancer, anal cancer, prostate cancer, and urinary bladder cancer).

You may not qualify if:

• Preoperative stoma which, according to the attending physician, prevents participation
• Difficulty swallowing or ileus conditions which, according to the treating physician, prevent participation
• Cognitive dysfunction which, according to the treating physician, prevents participation
• Need for an interpreter to communicate in Swedish

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• The Swedish Research Council: collaborator
• VGregion: collaborator
• Sjöbergstiftelsen: collaborator

Study Sites (1)

Jubileumskliniken, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (13)

• Patel P, Malipatlolla DK, Devarakonda S, Bull C, Rascon A, Nyman M, Stringer A, Tremaroli V, Steineck G, Sjoberg F. Dietary Oat Bran Reduces Systemic Inflammation in Mice Subjected to Pelvic Irradiation. Nutrients. 2020 Jul 22;12(8):2172. doi: 10.3390/nu12082172.

  PMID: 32707913 BACKGROUND

• Malipatlolla DK, Patel P, Sjoberg F, Devarakonda S, Kalm M, Angenete E, Lindskog EB, Grander R, Persson L, Stringer A, Wilderang U, Swanpalmer J, Kuhn HG, Steineck G, Bull C. Long-term mucosal injury and repair in a murine model of pelvic radiotherapy. Sci Rep. 2019 Sep 24;9(1):13803. doi: 10.1038/s41598-019-50023-4.

  PMID: 31551503 BACKGROUND

• Hedelin M, Skokic V, Wilderang U, Ahlin R, Bull C, Sjoberg F, Dunberger G, Bergmark K, Stringer A, Steineck G. Intake of citrus fruits and vegetables and the intensity of defecation urgency syndrome among gynecological cancer survivors. PLoS One. 2019 Jan 2;14(1):e0208115. doi: 10.1371/journal.pone.0208115. eCollection 2019.

  PMID: 30601820 BACKGROUND

• Ahlin R, Sjoberg F, Bull C, Steineck G, Hedelin M. [Differing dietary advice are given to gynaecological and prostate cancer patients receiving radiotherapy in Sweden]. Lakartidningen. 2018 Oct 9;115:FALY. Swedish.

  PMID: 30325475 BACKGROUND

• Sjoberg F, Malipatlolla DK, Patel P, Wilderang U, Kalm M, Steineck G, Bull C. Elastase as a potential biomarker for radiation-induced gut wall injury of the distal bowel in an experimental mouse model. Acta Oncol. 2018 Aug;57(8):1025-1030. doi: 10.1080/0284186X.2018.1438652. Epub 2018 Feb 15.

  PMID: 29447028 BACKGROUND

• Bull C, Malipatlolla D, Kalm M, Sjoberg F, Alevronta E, Grander R, Sultanian P, Persson L, Bostrom M, Eriksson Y, Swanpalmer J, Wold AE, Blomgren K, Bjork-Eriksson T, Steineck G. A novel mouse model of radiation-induced cancer survivorship diseases of the gut. Am J Physiol Gastrointest Liver Physiol. 2017 Nov 1;313(5):G456-G466. doi: 10.1152/ajpgi.00113.2017. Epub 2017 Jul 20.

  PMID: 28729245 BACKGROUND

• Steineck G, Sjoberg F, Skokic V, Bull C, Wilderang U, Alevronta E, Dunberger G, Bergmark K, Jornsten R. Late radiation-induced bowel syndromes, tobacco smoking, age at treatment and time since treatment - gynecological cancer survivors. Acta Oncol. 2017 May;56(5):682-691. doi: 10.1080/0284186X.2017.1307519. Epub 2017 Apr 1.

  PMID: 28366105 BACKGROUND

• Steineck G, Skokic V, Sjoberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderang U, Oh JH, Deasy JO, Jornsten R. Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors. PLoS One. 2017 Feb 3;12(2):e0171461. doi: 10.1371/journal.pone.0171461. eCollection 2017.

  PMID: 28158314 BACKGROUND

• Steineck G, Schmidt H, Alevronta E, Sjoberg F, Bull CM, Vordermark D. Toward Restored Bowel Health in Rectal Cancer Survivors. Semin Radiat Oncol. 2016 Jul;26(3):236-50. doi: 10.1016/j.semradonc.2016.03.002. Epub 2016 Mar 18.

  PMID: 27238476 BACKGROUND

• Lind H, Alevronta E, Steineck G, Waldenstrom AC, Nyberg T, Olsson C, Wilderang U, Dunberger G, Al-Abany M, Avall-Lundqvist E. Defecation into clothing without forewarning and mean radiation dose to bowel and anal-sphincter among gynecological cancer survivors. Acta Oncol. 2016 Nov;55(11):1285-1293. doi: 10.1080/0284186X.2016.1176247. Epub 2016 May 13.

  PMID: 27173757 BACKGROUND

• Thor M, Olsson CE, Oh JH, Petersen SE, Alsadius D, Bentzen L, Pettersson N, Muren LP, Waldenstrom AC, Hoyer M, Steineck G, Deasy JO. Relationships between dose to the gastro-intestinal tract and patient-reported symptom domains after radiotherapy for localized prostate cancer. Acta Oncol. 2015;54(9):1326-34. doi: 10.3109/0284186X.2015.1063779. Epub 2015 Sep 4.

  PMID: 26340136 BACKGROUND

• Alsadius D, Olsson C, Pettersson N, Tucker SL, Wilderang U, Steineck G. Patient-reported gastrointestinal symptoms among long-term survivors after radiation therapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):237-43. doi: 10.1016/j.radonc.2014.08.008. Epub 2014 Sep 4.

  PMID: 25201126 BACKGROUND

• Ahlin R, Bergmark K, Bull C, Devarakonda S, Landberg R, Sigvardsson I, Sjoberg F, Skokic V, Steineck G, Hedelin M. A Preparatory Study for a Randomized Controlled Trial of Dietary Fiber Intake During Adult Pelvic Radiotherapy. Front Nutr. 2021 Dec 7;8:756485. doi: 10.3389/fnut.2021.756485. eCollection 2021.

  PMID: 34950688 DERIVED

Related Links

• The study's website. Researchers who want to be able to log in, please write to Gunnar.Steineck@gu.se.

MeSH Terms

Conditions

Neoplasms; Rectal Neoplasms; Anus Neoplasms; Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Colonic Neoplasms; Flatulence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Colonic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gunnar N Steineck, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

• Maria Hedelin, PhD

  Göteborg University

  STUDY CHAIR

• Cecilia Bull, PhD

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Capsules that look alike, with dietary fiber or placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Professor

Model Details: Random allocation of patients and blinding of researchers, patients, healthcare professionals and outcome assessors.

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: September 1, 2020
• Study Start: September 2, 2020
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the primary publications and five years afterward.
• Access Criteria: Through the Swedish National Data Service, a national data repository run by a consortium consisting of nine universities.

Locations

SE (1)